Transcript Lesson 3

Lesson 3: Testing Medicines Clinical Trial
White space
White space
Have you ever had a
migraine or a bad
headache?
Challenge:
How are medicines tested during a clinical trial
Introduction: Scenario
Vocabulary:
clinical trial. control, placebo, sample size,
Simulate, Simulation, tradeoff
Materials: √
What did you do?
Procedure: √
Data: Results of Treatment Data Table
Results of a clinical Trial - Transparency 3.1
Analysis of a clinical trial - Student 3.1
Analysis: AQ 1 AQ 2, AQ3, AQ4,
Imagine the following:
1
You work for a company that develops medicines. You have
developed a medication for severe headaches and have tested it
on rats and mice to see if it has any negative effects. The tests on
animals showed no harmful effects, even at much higher doses
than you plan to use on humans. Now it is time to test the
medicine on human volunteers in a clinical trial.
What could happen to these volunteers after they take
the medicine?
How would you test the medicine to be sure it is
safe and improves the health of headache
patients? (answer in white space)
2
You will participate in a simulation of the trials
that are used to determine whether medicines
are effective and safe for people.
A simulation is an experience that is meant
to mimic, or be like, another experience.
Safety Note
Never taste materials or eat or drink in science class unless specifically
told to do so by your teacher.
Be sure that your work area is clean and free of any materials not needed for
this activity.
If you are allergic to lemons or other citrus fruits, juice drinks, or sugar, or if
you have any other health issue, such as diabetes, that limits what you can eat,
tell me teacher and do not taste the drink samples in this activity.
Keep track of all cups. Do not dip small cups into the large cups it will
contaminate the cups.
Do a simulated trial so we don’t test on students.
Before you can start the Lab Activity your
entire group must do all of the following:
1.
2.
3.
4.
5.
Complete the lesson page set up
Complete the vocabulary
Draw the data table
Materials Manager collects all safety cards
Materials manager must know how many
materials they are responsible for.
6. All students record data in notebook,
recorder records on separate sheet to turn in.
2
• The taste of the yellow lemon drink represents the
headache.
1. A perception that the orange lemon drink tastes better
than the yellow lemon drink represents feeling better.
2. A perception that the orange lemon drink tastes the same as
the yellow lemon drink represents no change in the
headache.
3. A perception that the orange lemon drink tastes worse than the
yellow lemon drink represents an improvement in the
headache but with side effects.
Results
Based on these results does the “medicine” appear to have worked?
Not all drinks were the same!
Yellow and one orange liquid was the same.
The orange liquid that was the same as the
yellow is called a placebo. (Control Group)
One of the orange liquids had twice as much
sugar. This was the one with the medicine
(sugar)
4
Results
Why was it important to have a group that did not receive the medicine?
This group allows for comparison, and helps investigators evaluate if changes are due to
the medicine or to some other factor.
Did Dr. Goldberger’s experiment on prisoners have a control?
No.
How could he have set up a control?
He could have included prisoners who continued to receive a healthy diet, but
underwent all of the other conditions of those who were on the restricted diet.
Results
Based on these results does the “medicine” appear to have worked?
Not all drinks were the same!
Yellow and one orange liquid was the same.
The orange liquid that was the same as the
yellow is called a placebo. (Control Group)
One of the orange liquids had twice as much
sugar. This was the one with the medicine
(sugar)
4
Clinical Trial
In a clinical trial that tests medicine, one group gets a pill or
liquid that contains an inactive ingredient, while a different
group gets a pill or liquid with the medicine that is being
tested.
In this simulation, the orange drink simulated taking a pill
or liquid.
The sugar represented the active ingredient.
What is a Placebo?
a control that simulates a medicine but doesn’t have the active
ingredient
Was there a control in the experiment we just did?
The orange drink without the extra sugar
In a real test of a medicine, one group receives a pill or liquid containing inactive
ingredients, while another group receives a pill or liquid containing the medicine.
In this model, the red food coloring was used to represent the idea of taking a
pill or liquid, while the sugar represented the active ingredient in the medicine.
These controls are part of one standard method for testing medicines, and that a pill or
Treatment used as a control in this way is called a
placebo.
Analysis Questions
1. What evidence do you have that the medicine (pink with sugar) does or does not
work to improve headaches?
In our class, __ people received the pink lemon drink with sugar, which represented
the medicine. Of those __ people, __ thought it tasted better than the yellow
lemon drink. One person thought it tasted the same and one thought it tasted
worse. This means that __ out of __ people felt better after taking the medicine
(although one suffered side effects). This shows that the medicine works to improve
headaches.
2. a. What is a placebo?
A placebo is a pill or liquid that looks like one containing medication, but it contains only
inactive ingredients.
2b. Why is a placebo group included in clinical trials?
The placebo group provides a control to be sure that it is the medicine and not some
other variable causing the improvement.
3. In this activity, if a person finds that the drink tastes worse, the headache is gone,
but there are side effects.
a. Assume that the side effects are mild, such as a slight stomachache. Explain why this
medicine should or should not be sold to people suffering from a headache. Are there
any trade-offs involved in your decision?
It should be sold.
Place a warning on the label.
Many people would be willing to trade off their severe headache for a slight
stomachache.
4. In this activity, if a person finds that the medicine tastes better or worse,
the headache is gone.
Review the results of this simulation.
Think about whether the medicine works and how often side effects occur. What would
you conclude about the safety and effectiveness of this medicine for treating
headaches?
Support your conclusion with evidence.